510(k) K021463

MODEL 1133 IVD PC VERSION by Sun Nuclear Corp. — Product Code IYE

K021463 is an FDA 510(k) premarket notification submitted by Sun Nuclear Corp. for the device "MODEL 1133 IVD PC VERSION". The FDA issued a decision of Substantially Equivalent on June 6, 2002. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Sun Nuclear Corp. has at least 10 other 510(k) clearances on record.